A BS TRACT: Background: Levodopa-carbidopa intestinal gel (LCIG) is administered directly to the small intestine of patients with advanced Parkinson's disease (APD) to help maintain stable plasma levodopa levels. Objective: The objective of this study was to investigate the effect of LCIG in reducing polypharmacy for the treatment of APD. Methods: The COmedication Study assessing Monoand cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS) is a large, real-world, multinational observational study investigating comedication use with LCIG. All enrolled patients had used LCIG for ≥12 months and data were collected cross-sectionally (study visit) and retrospectively. The primary endpoint was the percentage of patients using LCIG as monotherapy (without add-on PD medications) at initiation and at 3, 6, 9, and 12 months thereafter. Results: Overall, 409 patients were enrolled from 14 countries and were treated with LCIG for a mean of 35.8 AE 23.2 months. A total of 15.2% of patients initiated LCIG as monotherapy and 31.7% were receiving monotherapy at 12 months after initiation. The mean duration
The post-marketing international Global Adherence Project investigated adherence to disease-modifying therapy for relapsing-remitting multiple sclerosis. We report adherence data from the first 2 years in the Spanish subset of patients (n = 254 at baseline). The overall adherence rate was 85.4%. Patients taking intramuscular (IM) interferon-β (IFNβ)-1a were significantly more adherent (96.4%) compared with patients taking subcutaneous (SC) IFNβ-1a 22 µg (79.1%; p = 0.0064), SC IFNβ-1a 44 µg (79.6%; p = 0.0064) and glatiramer acetate (82.7%; p = 0.0184). At year 1 (n = 142), the overall adherence rate was 86.6%. Patients on IM IFNβ-1a were significantly more adherent than patients on SC IFNβ-1a 22 µg (93.9 vs. 66.7%; p = 0.0251). At year 2 (n = 131), the overall adherence rate was 82% (87.5% for IM IFNβ-1a, 80.0% for SC IFNβ-1a 22 µg, 77.8% for SC IFNβ-1a 44 µg, 85.2% for IFNβ-1b, and 80.0% for glatiramer acetate). In conclusion, adherence remained high among all disease-modifying therapies over the first 2 years of the study and was significantly higher for IM IFNβ-1a, at visit 1, compared with SC IFNβ-1a.
A BS TRACT: Background: There are limited data regarding the effectiveness of levodopa-carbidopa intestinal gel (LCIG) for dyskinesia. Objective: Compare the effectiveness of LCIG versus oral optimized medical treatment (OMT) for dyskinesia in patients with advanced Parkinson's disease (PD) using the Unified Dyskinesia Rating Scale (UDysRS). Methods: This phase 3b, open-label, multicenter, 12-week, interventional study (NCT02799381) randomized 63 LCIG naïve patients with advanced PD (UDysRS ≥30) to LCIG (N = 30) or OMT (N = 33) treatment. Dyskinesia impact was assessed at baseline through week 12 using the UDysRS. PD-related motor and non-motor symptoms, and quality of life (QoL) were also assessed. Results: Dyskinesias measured by UDysRS were significantly reduced in the LCIG group (n = 24; À17.37 AE 2.79) compared with the OMT group (n = 26; À2.33 AE 2.56) after 12 weeks (À15.05 AE 3.20; 95% CI, À21.47 to À8.63; P < 0.0001). At week 12, LCIG versus OMT also demonstrated significant improvements in "On" time without troublesome dyskinesia (P = 0.0001), QoL (P < 0.0001), global impression of change (P < 0.0001), activities of daily living (P = 0.0006), and Unified Parkinson's Disease Rating Scale (UPDRS) Part III (P = 0.0762). Treatment-emergent adverse events were reported in 27 (44.3%) patients (LCIG, 18 [64.3%]; OMT, 9 [27.3%]). Serious adverse events occurred in 2 (7.1%) LCIG-treated patients. Conclusions: LCIG significantly reduced dyskinesia compared with OMT. LCIG showed efficacy for treatment of troublesome dyskinesia in patients with advanced PD while demonstrating benefits in both motor and nonmotor symptoms and QoL.
Background and purpose GLORIA , a registry conducted with 375 advanced Parkinson's disease patients treated with levodopa‐carbidopa intestinal gel ( LCIG ) for 24 months in routine clinical care, demonstrated significant reductions from baseline in ‘off’ time and ‘on’ time with dyskinesia and improvements in the Non‐Motor Symptom Scale ( NMSS ) total and individual domain scores, and in Parkinson's Disease Questionnaire 8 item ( PDQ ‐8) total score. Methods Associations between baseline NMSS burden ( NMSB ), the multi‐domain NMSS total score and the PDQ ‐8 total score were investigated for 233 patients. Baseline NMSB was assigned to five numerical categories defined by the NMSS total cutoff scores (0–20, 21–40, 41–60, 61–80 and >80). Pearson and Spearman correlations were calculated at month 24. Results The response of LCIG was assessed using validated criteria after 24 months. The proportion of patients decreasing ≥ 30 NMSS score points was 47% in the most affected NMSB category ( NMSS total score > 80). A positive association was noted between baseline NMSB and NMSS total score (0.57, P < 0.0001), as well as between NMSS total score and PDQ ‐8 total score (0.46, P < 0.0001). Associations between improvements of the NMSS domain sleep/fatigue and PDQ ‐8 total score (0.32, P = 0.0001) as well as between the NMSS domain mood/cognition and PDQ ‐8 total score (0.37, P < 0.0001) were also shown. Conclusions This analysis demonstrated positive associations between NMSS baseline burden and improvements of non‐motor symptoms. Improvements of non‐motor symptoms were associated with improved quality of life in advanced parkinsonian patients during a 2‐year treatment with LCIG and reflect the long‐term non‐motor efficacy of this treatment.
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